In many cases, the end of the year gives you time to step back and take stock of the last 12 months. This is when many of us take a hard look at what worked and what did not, complete performance reviews, and formulate plans for the coming year. For me, it is all of those things plus a time when I u...

Basilea Pharmaceutica AG /
Basilea reports 2012 financials with a solid cash position and significant
milestones ahead
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.

* European regulatory review of ceftobiprole in pneumonia ongoing with
first potential approval in Q4 2013

* Toctino® agreement with potential U.S. filing by Stiefel early 2014

Basilea Pharmaceutica Ltd. (SIX: BSLN)
presented today full-year financial results for 2012 with an increased
year-end
cash position of CHF 344.0 million and a reduced net loss of CHF 53.0
million.
CFO Joachim Blatter will be leaving the company to pursue other
opportunities.
Ronald Scott, CEO will serve as interim CFO effective February 7, 2013.

2012 was a transformational year. Basilea took the strategic decision to
focus
its activities on anti-infective and oncology drugs and entered into an
agreement for its dermatology drug Toctino® (alitretinoin) with
Stiefel, a GSK
company, for a CHF 224.1 million initial payment and additional potential
payments related to the commercialization of Toctino® in the U.S.
Stiefel has
assumed responsibility for the development, manufacturing and
commercialization
of Toctino®. Basilea is eligible for a further milestone payment
related to the
launch of alitretinoin in the U.S. and will participate in future U.S.
product
sales. Toctino® 2012 sales through completion of the Stiefel agreement
were
CHF 20.2 million, in line with the company's guidance.

In 2012, Basilea advanced the isavuconazole phase 3 program in
collaboration
with Astellas and filed a ceftobiprole Marketing Authorization Application
submission for severe pneumonia in Europe. In addition, Basilea completed
its
U.S. phase 3 study for alitretinoin.

The isavuconazole SECURE phase 3 registration study, evaluating safety and
efficacy of once-daily isavuconazole versus twice-daily voriconazole for
the
primary treatment of life-threatening invasive fungal disease caused by
Aspergillus species completed patient recruitment. In addition, enrollment
into
the isavuconazole VITAL study, an open-label phase 3 study in the treatment
of
aspergillosis patients with pre-existing renal impairment or with invasive
fungal disease caused by rare but often fatal molds, has achieved its
initially
targeted recruitment of patients. Enrollment will continue to further
expand the
database on the use of isavuconazole in the primary treatment of diverse
rare
mold infections. Topline data from these two isavuconazole phase 3 studies
are
expected in the second half of 2013 and could result in a first potential
filing
in the first quarter of 2014. Under the agreement with Astellas, Basilea is
eligible for milestone payments related to filing, approval and sales, and
double-digit royalty payments. Furthermore, Basilea retains co-promotion
rights
on the drug and will evaluate these rights as the drug comes closer to the
market. The isavuconazole ACTIVE phase 3 study, evaluating the use of
isavuconazole i.v. and oral versus caspofungin i.v. followed by oral
voriconazole for the treatment of invasive Candida infections, will likely
continue to recruit into 2014. Basilea and its partner Astellas are
reviewing
potential filing strategies including a first filing of the SECURE and
VITAL
studies.

In 2012, Basilea also focused on bringing ceftobiprole to the market,
initially
for patients with severe lung infections. Basilea submitted a Marketing
Authorization Application in Europe for the treatment of pneumonia which
was
accepted for review in October 2012. Currently the company focuses on
answering
the questions received from the European agencies. Basilea had a
consultation
meeting with the FDA in 2012 and will continue its discussions with the FDA
to
receive the agency's final recommendation on the indications that could
potentially be supported by the existing data package. The FDA requested
that
Basilea conduct further analyses of the existing phase 3 dataset to assist
FDA
in developing a final recommendation. A follow-up consultation meeting for
a
discussion of the data is envisaged in the second quarter of 2013. Basilea
is
managing the ceftobiprole supply chain to support a potential regulatory
approval and launch and is engaged in discussions with potential partners.

Basilea's commitment to address the medical challenge of resistance in the
areas
of anti-infectives and oncology is also reflected in its phase 1 programs
with
innovative compounds from in-house research, addressing high medical needs
in
these focus areas. The novel antibiotic BAL30072 is intended for the
treatment
of multidrug-resistant Gram-negative bacteria where current antibiotics
often
fail, and the new oncology drug BAL101553 focuses on the treatment of
tumors
resistant to current cancer therapies. Basilea made substantial progress
during
2012 in advancing these compounds in clinical phase 1 development. BAL30072
moved into its next stage of phase 1 testing and BAL101553 is anticipated
to
move into phase 2a studies in 2013.

Ronald Scott, CEO stated: "We made significant achievements in 2012.
Through the
Toctino transaction we improved our cash position and we will continue to
prudently invest our resources to achieve our key value-driving events. Now
we
are focused on our important milestones for 2013, including the potential
approval of ceftobiprole in Europe and first anticipated isavuconazole
phase 3
topline data." He added: "Basilea is uniquely positioned through our
innovative
drug portfolio to address the increasing threat posed by multi-drug
resistant
infections and drug resistant cancers for which there are currently limited
treatments available. The critical need to address drug resistance is
gaining
increasing awareness. Recent measures taken by several countries further
encourage the development of novel antibiotics and antifungals for the
treatment
of drug-resistant life-threatening infections by providing potential
benefits
that could result in shorter development and regulatory timelines and
longer
market exclusivity." Related to the departure of Joachim Blatter he said:
"We
want to thank Joachim for his contributions, and wish him all the best for
his
new endeavors."

Product sales in 2012 for Toctino® were within guidance amounting to
CHF 20.2
million, through July 2012, when the Stiefel transaction closed (full-year
2011: CHF 31.0 million).

Contract revenue in 2012 amounted to CHF 37.4 million (2011: CHF 35.2
million),
including CHF 16.1 million related to the agreement with Stiefel on
Toctino®,
CHF 12.8 million related to Toctino® distribution agreements and CHF
8.2 million
related to the license agreement with Astellas for isavuconazole. Total
operating income decreased to CHF 58.3 million in 2012 (2011: CHF 66.8
million)
primarily due to the shorter product sales period as a result of the
agreement
with Stiefel on Toctino® in July 2012.

Research and development expenses amounted to CHF 58.9 million in 2012,
compared
to CHF 70.0 million in 2011. This decrease is mainly due to the completion
of
the alitretinoin phase 3 U.S. study in the first half of 2012 and Basilea
fulfilling its financial participation commitment in the development of
isavuconazole under the license agreement with Astellas. Selling, general
and
administrative expenses decreased to CHF 45.9 million in 2012 (2011: CHF
51.7
million) primarily due to closing Basilea's commercial organizations
following
its Toctino® agreement with Stiefel in the second half of 2012.

In 2012, the operating loss decreased to CHF 50.8 million from CHF 57.3
million
in 2011, mainly due to lower research and development costs as well as
lower
selling, general and administrative expenses. As a result of this, the
average
monthly operating loss for 2012 was CHF 4.2 million. The net loss 2012
amounted
to CHF 53.0 million, compared to CHF 57.6 million in 2011.

2012 basic and diluted loss per share amounted to CHF 5.53 compared to
basic and
diluted loss per share of CHF 6.01 in 2011.

In 2012, the net cash provided by operating activities was CHF 148.2
million as
compared to net cash used by operating activities of CHF 82.4 million in
2011,
mainly due to the upfront payment of CHF 224.1 million received from
Stiefel for
the Toctino® agreement. Combined cash and short-term investments
increased to
CHF 344.0 million as of December 31, 2012, compared to CHF 197.1 million at
year-end 2011.

Financial outlook

Total operating expenses for 2013 are estimated to decrease to around CHF 7
to
8 million per month primarily due to the Toctino® transaction and
Basilea having
fulfilled in 2012 its financial participation commitment related to the
development of isavuconazole. Basilea's average operating loss in 2013 is
estimated at around CHF 4 to 5 million per month.

Isavuconazole demonstrated excellent in-vitro and in-vivo coverage of a
broad
range of yeasts (such as Candida species) and molds (such as Aspergillus
species) as well as in-vitro activity against less prevalent but often
fatal
molds such as Mucorales spp. It has U.S. FDA fast-track status. In clinical
studies to date it achieved predictable drug levels and high oral
bioavailability suggesting the potential for predictable dosing and a
switch
from i.v. administration to convenient once-daily oral dosing.

Ceftobiprole has unique broad-spectrum activity against Gram-positive
bacteria,
including methicillin-resistant and vancomycin-resistant Staphylococcus
aureus
(MRSA, VRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP) as
well as
Gram-negative pathogens, including Enterobacteriaceae and Pseudomonas
aeruginosa. Ceftobiprole has met the study endpoints in several phase III
studies and has shown a typical cephalosporin safety profile.

The investigational drug has demonstrated broad in-vitro and in-vivo
coverage of
Gram-negative pathogens including multidrug-resistant Pseudomonas
aeruginosa and
Acinetobacter baumannii. It has robust activity against common strains of
bacteria that produce antibiotic-inactivating enzymes
including extended-spectrum beta-lactamases (ESBL)
and metallo-beta-lactamases such as the New Delhi metallo-beta-lactamase 1
(NDM-1). In addition, BAL30072 has been shown to
enhance the activity of antibiotics from the penem class.

BAL101553 disrupts the intracellular microtubule network that is essential
for
cell division and has shown potent activity in many tumor cell lines that
are
insensitive or resistant to taxanes or other microtubule-targeting agents.
In
contrast to currently available microtubule-targeting agents that are
derived
from complex natural products, BAL101553 is a simpler synthetic molecule
that
bypasses some of the resistance mechanisms associated with existing drugs.
BAL101553 was developed as a highly water-soluble prodrug of Basilea's
BAL27862
with anticipated good oral bioavailability and an injectable formulation
without
potentially harmful solubilizers.

Toctino® (oral alitretinoin) - the only licensed drug for systemic use
in adults
with severe chronic hand eczema unresponsive to potent topical
corticosteroids

Toctino® was developed and successfully brought to market by Basilea.
In the
U.S., oral alitretinoin is an investigational drug in phase III and not yet
approved by the FDA. In July 2012, Basilea completed an agreement for
Toctino®
with Stiefel, a GSK company.

Conference call

Basilea Pharmaceutica Ltd. invites you to participate in a conference call
on
Thursday, February 7, 2013, 4 p.m. (CET), during which the company will
discuss
today's press release.

The shareholders of Basilea Pharmaceutica Ltd. are informed that the
Ordinary
General Meeting of Shareholders of Basilea Pharmaceutica Ltd. will take
place on
Tuesday, April 9, 2013 at 2 p.m. at the Hilton Hotel in Basel, Switzerland.
The
invitation will be published in the Swiss Official Gazette of Commerce
(Schweizerisches Handelsamtsblatt, SHAB). Shareholders who are recorded in
the
share register with voting rights on March 28, 2013 will be entitled to
participate and exercise their voting rights.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and
listed on
the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research
and
development operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd., the company focuses on innovative pharmaceutical
products in
the therapeutic areas of bacterial infections, fungal infections and
oncology,
targeting the medical challenge of rising resistance and non-response to
current
treatment options.

Disclaimer

This communication expressly or implicitly contains certain forward-looking
statements concerning Basilea Pharmaceutica Ltd. and its business. Such
statements involve certain known and unknown risks, uncertainties and other
factors, which could cause the actual results, financial condition,
performance
or achievements of Basilea Pharmaceutica Ltd. to be materially different
from
any future results, performance or achievements expressed or implied by
such
forward-looking statements. Basilea Pharmaceutica Ltd. is providing this
communication as of this date and does not undertake to
update any forward-looking statements contained herein as a result of new
information, future events or otherwise.

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